Eli Lilly and Co. just hit another bump in the road in its quest to push deeper into treatments for skin diseases, the third setback this year for the Indianapolis-based drugmaker from the U.S Food and Drug Administration.
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Illuccix was first approved by the FDA in December 2021. The imaging agent is designed to target and “light up” cancerous cells, making it easier for oncologists to determine through a PET scan if the cells have spread to areas outside the prostate.
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The drug has been closely watched by medical professionals and is viewed by financial analysts as a possible blockbuster, with potential annual sales in the billions of dollars.
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The drug, called tirzepatide, has been closely watched by medical professionals and is viewed by financial analysts as possible blockbuster, with potential annual sales in the billions of dollars.
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Dr. Helen Bernie said on a Dec. 10 panel hosted by the U.S. Food and Drug Administration that serum testosterone “is one of the most powerful yet underutilized biomarkers for men’s health.”
The U.S. Food and Drug Administration said four companies continued to sell the infant formula for days or weeks, despite a Nov. 11 recall of all products in the outbreak that has sickened more than 50 babies in 19 states.
The company recalled thousands of cases of heat-and-eat linguine, fettucine, penne and other pastas sold at grocery stores nationwide.
President Donald Trump signed a memo Tuesday that directs the FDA and other agencies to step up enforcement against ubiquitous prescription drug ads on TV, websites and social media.
The revamped vaccines target a newer version of the continuously evolving virus and are set to begin shipping soon.
U.S. health officials are warning Americans about the risks of an opioid-like ingredient increasingly added to energy drinks, gummies and supplements sold at gas stations and convenience stores, recommending a nationwide ban.
Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s Center for Drug Evaluation and Research, which regulates the safety and effectiveness of all U.S. drugs.
The idea could help the administration achieve one of President Donald Trump’s main health-care goals: ensuring foreign countries aren’t getting a better deal on drugs.
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
Nestle joins Kraft Heinz and General Mills as major food companies to pledge they would remove artificial dyes from their U.S. products.
Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months.
FDA leaders estimate more than 100 million Americans would still be eligible for the shots under the new framework.
It would be a sweeping change for U.S. food producers, who would likely replace the dyes with natural substitutes.
The Trump administration’s recent announcement that it plans to eliminate about 3,500 FDA jobs is creating uncertainty among Indianapolis-area companies that interact with the federal agency.
Weeks after ordering all Food and Drug Administration employees back into the office, the agency is allowing some of its most prized staffers to work remotely.
The plan means cuts at the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare and Medicaid Services.
Ultraprocessed foods have been linked to a host of negative health effects, from obesity and diabetes to heart disease, depression, dementia and more. And they make up most of the U.S. diet.
Food manufacturers will have until January 2027 to remove the dye from their products, while makers of ingested drugs have until January 2028 to do the same.
The Food and Drug Administration is on the cusp of deciding whether to ban a controversial bright cherry-red dye that has been linked to cancer in animals.
The proposal from the Food and Drug Administration and mandated by Congress is intended to reassure consumers about the safety of makeup, baby powder and other personal care products.
